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History of Changes for Study: NCT00733863
Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.
Latest version (submitted February 8, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 11, 2008 None (earliest Version on record)
2 October 28, 2008 Study Status
3 January 13, 2009 Outcome Measures, Study Status, Contacts/Locations, Eligibility and Arms and Interventions
4 March 31, 2009 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions, Study Design, Eligibility and Study Identification
5 May 10, 2010 Recruitment Status, Study Status and Study Identification
6 February 8, 2020 Study Status
Comparison Format:

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Study NCT00733863
Submitted Date:  August 11, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: CAD106A2201
Brief Title: Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.
Official Title: A 52-Week,Multi-Center,Randomized,Double-Blind,Placebo-Controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2008
Overall Status: Recruiting
Study Start: July 2008
Primary Completion: January 2010 [Anticipated]
Study Completion:
First Submitted: August 8, 2008
First Submitted that
Met QC Criteria:
August 11, 2008
First Posted: August 13, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 11, 2008
Last Update Posted: August 13, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Novartis
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.
Detailed Description:
Open or close this module Conditions
Conditions: Alzheimer Disease
Keywords: Active immunization
Alzheimer disease
Antibody
Central Nervous System Diseases
Neurodegenerative diseases
Vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: 1 Biological: CAD106
Placebo Comparator: 2 Biological: Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
Secondary Outcome Measures:
1. Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52.
Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers:
Criteria:

Inclusion Criteria:

  • Male and/or female patients between 40 and 85 years of age (both inclusive).
  • Diagnosis of Mild Alzheimer's Disease
  • Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks

Exclusion Criteria:

  • Previously participated in an AD vaccine study and received active treatment
  • History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
  • History or presence of seizures and/or cerebrovascular disease.
  • Presence of an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
Open or close this module Contacts/Locations
Central Contact Person: Novartis Pharmaceuticals
Telephone: 41 61 324 1111
Study Officials: Novartis Pharmaceuticals
Principal Investigator
Novartis
Locations: Switzerland
NeuroPsychologieZentrum
[Recruiting]
Basel, Switzerland
Contact:Contact: Sybille Bertolo, MD +41 61 265 20 42 sbertoli@uhbs.ch
Contact:Principal Investigator: Prof Kressig
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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